The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Reusable Bronchial Biopsy Forceps.
Device ID | K022398 |
510k Number | K022398 |
Device Name: | REUSABLE BRONCHIAL BIOPSY FORCEPS |
Classification | Forceps, Biopsy, Bronchoscope (non-rigid) |
Applicant | BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
Contact | Cindy Ellis |
Correspondent | Cindy Ellis BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
Product Code | BWH |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-23 |
Decision Date | 2002-10-11 |
Summary: | summary |